Tarceva(R) Delivers Benefits Across Broad Range of NSCLC Patients - Confirmed by New Data

Chicago, Illinois (ots/PRNewswire) -

- Tarceva Extends Length and Quality of Life in Largest Non-Small
Cell Lung Cancer (NSCLC) Phase IV Study Ever Conducted

- For non-US and non-UK Media Only

New data presented at ASCO 2008 from TRUST(1), the largest
non-small cell lung cancer (NSCLC) Phase IV trial ever conducted,
show that a broad range of NSCLC patients treated with Tarceva
(erlotinib) experience clinical benefits including longer survival,
better quality of life, control of disease symptoms and control of
cancer progression. NSCLC is the most common and deadly form of lung
cancer suffered by over one million people worldwide(2).

This analysis of 6,809 patients in 52 countries across Asia,
Europe and the Americas showed that Tarceva's beneficial effects are
not limited to certain subgroups, but extend to all types of patients
with this debilitating disease(1).

Patients across a broad range of clinical characteristics -
gender, ethnicity, smoking status or tumor histology1 - lived an
average of 14.3 weeks(1) without their disease progressing
(progression-free survival or PFS). While TRUST is a single-arm
study, a PFS of 14.3 weeks is almost double the PFS (7.2 weeks) seen
in the control arm of the landmark BR.21 study(3) which resulted in
Tarceva's approval four years ago.

In addition, all patient groups in TRUST (including male current
and former smokers, and males who have never smoked) experienced an
impressive disease control rate (DCR) of approximately 70% at the
time of analysis(1). DCR measures if the tumor disappeared, reduced
in size or did not progress, and is strongly associated with
increased survival and quality of life.

"These results underline that Tarceva is a very valuable drug
with proven efficacy and safety in the fight against NSCLC," said Dr
Martin Reck of the Department of Thoracic Oncology, Hospital
Grosshansdorf, Germany. "TRUST demonstrates in routine day-to-day
practice that Tarceva delivers benefits across a wide range of
patients irrespective of clinical characteristics."

Realizing Tarceva's Potential

Another important study unveiled at ASCO is FAST-ACT(4), a phase
II trial of Tarceva administered sequentially with platinum-based
chemotherapy to Asian patients. The study showed a significant
improvement with patients on Tarceva living 7.2 months without their
disease progressing. The FAST-ACT study is the first time that an
epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)
has shown promise in first-line NSCLC when administered sequentially
with standard chemotherapy. FAST-ACT also points to Tarceva's
potential across multiple treatment settings.

In a global alliance comprising OSI Pharmaceuticals, Genentech
and Roche, almost 130 clinical studies are being conducted with
Tarceva at earlier stages of the disease and in combination with
other treatments including Avastin, to further evaluate its
life-extending benefits for patients with lung cancer.

For further information and all the latest news on Tarceva and
lung cancer, please visit http://www.tarcevapressoffice.com.

Notes to Editor

About TRUST

TRUST, the largest ongoing study of Tarceva in lung cancer
worldwide, involves over 7,000 NSCLC patients from 52 countries
across Asia, Europe and the Americas. It is a multi-center, global,
Phase IV study of Tarceva for the second- or third-line treatment of
patients with advanced NSCLC. Also an expanded access program, TRUST
enabled thousands of patients worldwide with advanced NSCLC to
receive early access to Tarceva by filling the gap between the
submission date of the new drug application and the date of final
approval.

About FAST-ACT

FAST-ACT is a Phase II randomized, double-blind trial of
sequential Tarceva and chemotherapy as first-line treatment in Asian
patients with stage IIIB/IV NSCLC. The study involved 154 patients
enrolled from Australia, and throughout Asia.

About BR.21

EU approval for Tarceva was based on a pivotal Phase III study,
BR.21, published in the New England Journal of Medicine. BR.21 was
conducted by the National Cancer Institute of Canada Clinical Trials
Group, in collaboration with OSI Pharmaceuticals, with the
participation of 86 sites from 17 countries around the world. This
study involved 731 patients with advanced NSCLC whose cancers had
progressed after first- or second-line chemotherapy and compared
patients receiving Tarceva monotherapy with placebo.

The key study results were:
- Treatment with Tarceva in patients with advanced NSCLC resulted in
significantly longer survival compared to placebo, a 42.5% improvement
(6.7 months vs. 4.7 months).
- 31% of patients receiving Tarceva were alive at one year compared to
22% in the placebo arm.
- Patients receiving Tarceva had stability or control of their lung
cancer-related symptoms such as cough, shortness of breath and pain,
for significantly longer.
- Patients also had a superior quality of life and improved physical
function compared to those on placebo.
- The benefits of Tarceva were shown in a broad spectrum of patients

About Tarceva

Tarceva is the first and only EGFR oral targeted agent with
proven and significant survival and symptom benefit in a broad range
of patients with advanced lung and pancreatic cancer. Currently most
lung and pancreatic cancer patients are treated wholly with
chemotherapy which can be very debilitating due to its toxic nature.
Tarceva works differently than chemotherapy by specifically targeting
tumor cells, and avoids most of the typical side-effects of
chemotherapy.

Tarceva has been approved in the European Union since September
2005 and in the US since November 2004 for the treatment of patients
with locally advanced or metastatic NSCLC after failure of at least
one prior chemotherapy regimen. Furthermore, Tarceva, in combination
with chemotherapy, is the first treatment in over a decade to have
shown a significant survival benefit in treating patients with
pancreatic cancer. It is approved in the US, in combination with
gemcitabine, for the first-line treatment of patients with locally
advanced, unresectable or metastatic pancreatic cancer and in the EU
for treatment of metastatic pancreatic cancer. Since its initial
launch four years ago, Tarceva has been used to treat more than
200,000 patients and has been approved in 85 countries worldwide.

Roche in Oncology

The Roche Group, including its members Genentech in the United
States and Chugai in Japan, is the world's leading provider of cancer
care products, including anti-cancer treatments, supportive care
products and diagnostics. Its oncology business includes an
unprecedented five products proven to provide survival benefit in
different major tumor indications: Avastin, Herceptin, and Xeloda in
advanced-stage breast cancer, Herceptin in early-stage HER2-positive
breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xeloda
in colorectal cancer, Avastin and Tarceva in NSCLC and Tarceva in
pancreatic cancer. For further information on Roche please go to
http://www.roche.com.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolic disorders and diseases
of the central nervous system. Additional information is available on
the internet at http://www.roche.com.

References
1. Allan S et al. Efficacy of erlotinib in patients with
advanced non-small cell lung cancer (NSCLC) relative to clinical
characteristics: subset analysis from the TRUST study. Poster
presented at ASCO 2008 Annual Meeting, Chicago, US.
2. IARC. GLOBOCAN 2002. Cancer incidence, Mortality and
Prevalence Worldwide.
3. F. Shepherd et al. Erlotinib in Previously Treated
Non-Small Cell Lung Cancer, A Trial of the National Cancer Institute
Of Canada Clinical Trials Group. N Engl J Med 2005; 353:123-32.
4. Lee J-S et al. FAST-ACT: a phase II randomized double-blind
trial of sequential erlotinib and chemotherapy as 1st-line treatment
in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
Abstract #8031: ASCO 2008 Annual Meeting, Chicago, US.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact Information For more information on TRUST and Tarceva or to
arrange an interview with Dr Martin Reck, please contact: Lester B.
Davis International Communications Manager, Tarceva, F. Hoffmann-La
Roche Ltd, Direct: +41-61-688-20-78, Mobile: +41-79-618-76-73,
E-Mail: lester.davis@roche.com ; May Baccari, Resolute
Communications, Direct: +41-61-688-20-78, Mobile: +41-79-618-76-73,
may.baccari@resolutecommunications.com .